Clinical Trials Logo

Clinical Trial Summary

The study is to compare the rate and extent of absorption of a generic formulation with that of a reference for mulation when given as equal labeled dose. The study will be randomized, open-label, single dose, two way crossover design with two-period, two-treatment and two-sequence under fasting condition and at least 7 days washout period between the doses


Clinical Trial Description

Title A Bioequivalence study of a randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence of Esomeprazole magnesium dihydrate 40 mg tablets relative to Nexium 40 mg tablets in healthy Thai volunteers under fasting condition. Objective The primary objective is to compare the rate and extent of absorption of a generic formulation with that of a reference formulation when given as equal labeled dose. The secondary objective is to evaluate the safety after oral administration of both test and reference formulation in healthy Thai volunteers. Study Design Randomized, open-label, single dose, two-way crossover design with two-period, two-treatment, and two-sequence under fasting condition and at least 7 days washout period between the doses. Sample Size 30 Healthy Human Thai subjects. Two extra subjects if available, may be checked-in on the day of check in of period-I to compensate for any dropout prior to dosing of period-I. These subjects will be dosed if there are dropouts prior to dosing in period-I. If there are no dropouts, these subjects will be checked-out without being dosed after completion of dosing in period-I. Drug-Product Test-Product: Esomeprazole 40 mg gastro-resistant tablets Reference-product: Nexium® 40 mg tablets Manufactured by: AstraZeneca AB, Kingdom of Sweden Administration After an overnight fasting at clinical facility of at least 10 hours, each volunteer will receive a single dose of Esomeprazole 40 mg gastro-resistant tablets of either test or reference with 250 mL of drinking water. Each volunteer will be allowed to drink water as desire except 1 hour before and after drug administration. The formulation is given in a crossover fashion as per the randomization schedule. After the administration, the subject's oral cavity will be checked by using flashlight to confirm complete medication and fluid consumption by pharmacist. Blood Schedule In each period, a total of 21 blood samples (approximately 5 mL each) will be collected pre-dose (0.00 hour) and at 0.25, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 5.00, 6.00, 8.00, 10.00, 12.00 and 16.00 hours after study drug administration, respectively. Sample Collection Blood samples will be collected through an indwelling catheter placed in a vein using disposable syringe or through fresh venipuncture with disposable syringes and needles. Approximately 5 mL blood sample will be withdrawn and transferred to sample collection pre-labeled tubes containing K3EDTA as anticoagulant at each sampling time point. Invert collection tube 3-5 times immediately after collection. After collection, all samples transfer into centrifugation room at controlled temperature (2-8 °C). Samples will be centrifuged at 4000 rpm for 5 minutes at 4±2°C. After centrifugation, the plasma samples will be aliquoted into two pre-labeled cryovials for approximately 1 mL in original cryovial and leaving the remaining volume for the duplicate cryovial. The plasma will be added in the pre-added buffer of 0.5M Sodium hydrogen carbonate in Milli-Q water to the pre-labeled cryovials, proper adjustments for buffer addition which will be permissible but the final composition of buffer in plasma will be 5% of total volume. The cryovials will be then vortexed for 30 seconds on multitube vortexer. Cryovials containing plasma sample will be stored at -70±10 °C. Analytical Method Esomeprazole plasma concentration will be assayed as per international Guidelines/In-house SOP by using a UPLC-MS/MS method. Pharmacokinetic Parameters Primary pharmacokinetic parameter: Cmax, AUC0→t and AUC0→∞ and secondary pharmacokinetic parameter: Tmax, T1/2, Kel, AUC0→t/AUC0→∞ will be determined from the plasma concentration data of analytes. Statistical Analysis ANOVA, two one-sided tests for bioequivalence, for log-transformed pharmacokinetic parameters Cmax, AUC0→t and AUC0→∞ will be performed. Acceptance Criteria for Bioequivalence To be considered as bioequivalent, the 90% Confidence Interval of the geometric means ratio of Cmax, AUC0→t and AUC0→∞ of Esomeprazole of test and reference products should be in the interval of 80.00-125.00% for the log-transformed data. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06233097
Study type Interventional
Source Bio-innova Co., Ltd
Contact Sasitorn Kittivoravitkul, Ph.D.
Phone 022549008
Email sasitorn_k@bio-innova.com
Status Not yet recruiting
Phase Phase 1
Start date August 29, 2024
Completion date October 12, 2024

See also
  Status Clinical Trial Phase
Completed NCT05483998 - A Study to Evaluate Single and Multiple Doses of TLC-2716 in Healthy Participants Phase 1
Recruiting NCT02235012 - Cognitive Biases Under Ketamine N/A
Recruiting NCT02417714 - Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Completed NCT05088343 - Effect of Hetrombopag on the Pharmacokinetics of Rosuvastatin in Healthy Subjects Phase 1
Completed NCT04418973 - Analysis of Breath Volatile Organic Compounds After Dyspnea Induced in the Healthy Subject. N/A
Not yet recruiting NCT06248801 - Vildagliptin and Metformin Tablets 50/1000 mg Relative to GALVUS MET (50mg/1000 mg) Tablets Phase 1
Terminated NCT04068259 - Single Ascending Dose Study of PBI-4547 in Healthy Subjects Phase 1
Completed NCT03279302 - Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects Phase 1
Not yet recruiting NCT06233162 - Febuxostat 80 mg Tablets Relative to Feburic® 80 mg Tablets Phase 1
Recruiting NCT04159844 - Evaluation of the Stiffness and Pressure Applied on the Lower Leg by a New Compression Bandage on Healthy Subjects N/A
Completed NCT06137911 - Evaluation of Safety, Tolerability & Pharmacokinetics of JYP0061 in Healthy Adults. Phase 1
Completed NCT04849286 - Measurement of HTL0016878 in Cerebrospinal Fluid Phase 1
Not yet recruiting NCT06233227 - Dutasteride Soft Capsule 0.5 mg Relative to Avodart 0.5 mg Soft Capsule Phase 1
Completed NCT04096157 - A Study to Assess Isavuconazole Following a Single Dose of Isavuconazonium Sulfate Intravenous Solution Via Nasogastric (NG) Tube Compared to a Single Dose of Oral Capsules Under Fasting Conditions in Healthy Participants Phase 1
Completed NCT01200368 - Trial Evaluating a 13-valent Pneumococcal Conjugate Vaccine Given With Diphtheria, Tetanus, and Acellular Pertussis Vaccine (DTaP) in Healthy Japanese Infants Phase 3
Recruiting NCT05805033 - Peri-Implant Soft Tissue Integration in Humans: Influence of Material N/A
Completed NCT04027803 - Comparative Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of Single Intravenous Doses of BCD-148 and Soliris® Phase 1
Recruiting NCT03467880 - Multicenter Study of Impulse Oscillometry in Chinese N/A
Completed NCT02903095 - Single Ascending Dose Study of TD-1439 in Healthy Subjects Phase 1
Active, not recruiting NCT02341508 - A Phase 1a, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Lpathomab in Healthy Volunteers Phase 1